Pharmaceutical manufacturers and their suppliers face a heavy burden to meet quality standards required by international legislation. Not every manufacturer has the resource available to test, nor the expertise or equipment to test and interpret results.

Whether applying the pharmacopoeia monographs, transferring in your own methods, or developing new methods on your behalf, we can provide GMP QC testing services for your APIs, excipients and drug products.

We can also detect impurities in the production of raw materials that contain amino acids. Our equipment is suited to analysis conforming to European Pharmacopoeial method 2.2.56, which was adopted in 2014. The test is sensitive to impurities at a threshold of 0.05%, as required by the EP monograph, and capable of determining whether the overall impurity level exceeds the limit of 0.5%.

If you are unsure about what tests are needed, we will consult and advise on the best approach. We can also discuss topics such as harmonisation or other upcoming Pharmacopoeial changes and how this may affect your business.

Pharmacopoeia Monographs

Our experienced scientists, detailed knowledge of testing and our extensive equipment capabilities means that we are able to offer analysis for the majority of pharmacopoeia monographs including:

Techniques

RSSL can help you understand the physical parameters affecting the performance and efficacy of your products and support QC release for GMP by performing testing in accordance with pharmacopoeia monographs and client methods.

RSSL will help you to ensure the microbiological quality of your raw material, finished product and medical device to demonstrate regulatory compliance and prove that you have good hygienic production procedures.

RSSL can support the implementation of the upcoming elemental impurities changes. We can develop and validate methods to determine levels of elemental impurities present in accordance with ICH Q3D guidance.

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